Clinical Trials Logo

Clinical Trial Summary

The primary objective is to determine the safety and feasibility of administering R-MVST cells to patients with refractory viral reactivation and/or symptomatic disease caused by Epstein Barr Virus (EBV), cytomegalovirus (CMV), adenovirus (ADV) or BK virus. R-MVST cells will be generated on-demand from the closest partially human leukocyte antigen (HLA)-matched (minimum haploidentical) healthy donors or from the original allo-transplant donor if available. The investigator will closely monitor the recipients for potential toxicities including graft-versus-host disease (GVHD) post-infusion. Secondary objectives are to determine the effect of R-MVST infusion on viral load, possible recovery of antiviral immunity post-infusion and for evidence of clinical responses and overall survival. Recipients will be monitored for secondary graft failure at day 28 post R-MVST infusion.


Clinical Trial Description

Starting from childhood, majority of healthy humans are exposed to common viruses such as CMV, EBV, BK and related human polyomaviruses and herpes viruses. Under normal circumstances those infections are well controlled by the adaptive immune system, but never eliminated. Instead, they are fairly inactive and produce relatively few consequences or symptoms. However, when T cell mediated immunity is suppressed, those dormant viruses reactivate and can cause a significant end-organ or severe systemic syndrome. This viral reactivation contributes to morbidity and mortality in recipients of allogeneic stem cell transplant (HCT) and solid organ transplants (SOT), and can affect many other patients who receive immunosuppressive therapies or have underlying pathology that affects T cell function, including patients with autoimmune diseases, congenital immunodeficiencies or HIV/AIDS. As a result of a weakened immune response, conventional antiviral prophylaxis or treatment with acyclovir and ganciclovir/foscarnet (for CMV) or rituximab (against EBV) are not always effective. The main purpose of this study is to test whether giving an experimental cell product can treat the viral infection in patients who have conditions that cause poor function of their immune system, such as infections caused by viruses such as Cytomegalovirus (CMV), Epstein-Barr Virus (EBV), BK virus, or adenovirus. The cell product is called rapidly generated virus specific T cells or R-MVST. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05183490
Study type Interventional
Source Columbia University
Contact Nurse Navigator
Phone (212) 342 5162
Email cancerclinicaltrials@cumc.columbia.edu
Status Recruiting
Phase Phase 1
Start date May 3, 2022
Completion date December 2026

See also
  Status Clinical Trial Phase
Terminated NCT03950414 - A Dose-Escalation Study Evaluating Safety and Tolerability of Viral-Specific T Cells Against CMV in Adult Solid Organ Transplant Recipients Phase 1
Recruiting NCT04690933 - AntiCMV molécules Monitoring in Real-life in Stem Cell Recipients
Withdrawn NCT04936971 - Introduction of mTor Inhibitors and the Activation of the Cytomegalovirus (CMV) -Specific Cellular Immune Response Phase 4
Recruiting NCT02671318 - Conversion to Sirolimus: Effects in Cytomegalovirus Infection Recurrence Phase 4
Completed NCT01325636 - Injection of CD4 and CD8 + T Cells Anti-Cytomegalovirus (CMV) or Anti-adenovirus Phase 1/Phase 2
Recruiting NCT00228202 - Genotyping of Cytomegalovirus From Patients in Israel N/A
Completed NCT00031421 - Neonatal CMV-Ganciclovir Follow-up Study N/A
Completed NCT00005496 - Inflammation, Infection, and Future Cardiovascular Risk N/A
Terminated NCT03262194 - Relevance of Gastric Aspirate in HCMV Detection
Completed NCT04478474 - Cytomegalovirus (CMV) Viremia and Disease Occurrence in Pediatric Allogeneic Stem Cell Transplantation Recipients
Recruiting NCT05370976 - Efficacy and Safety of Cytotect®CP, Hyperimmune Anti-CMV IVIg as CMV Prophylaxis in Patients Developing Acute Grade II-IV GVHD After Allogeneic Hematopoietic Cell Transplantation. Phase 2
Active, not recruiting NCT02943057 - Topical 2% Ganciclovir Eye Drop for CMV Anterior Uveitis / Endotheliitis Phase 4
Completed NCT02538172 - Cell-mediated Immunity for Prevention of CMV Disease N/A
Completed NCT02642822 - The Epidemiologic Study of Human Cytomegalovirus(CMV) in Female Students of Xiamen University N/A
Completed NCT02134184 - The Influence of Chronic CMV Infection on Influenza Vaccine Responses Phase 4
Completed NCT00673868 - Cytomegalovirus (CMV) Specific Cytotoxic T Lymphocytes (CTL) When Used for Prophylaxis Against CMV in Recipients of Allogeneic, T Cell Depleted Stem Cell Transplants Phase 1
Active, not recruiting NCT05089630 - A Study of Safety and Immune Response to Different Doses of a Cytomegalovirus Vaccine in Healthy Adults Phase 1/Phase 2
Not yet recruiting NCT06058858 - Incidence and Risks Factors of CMV Reactivation in Patients Receiving of CAR-T Cells for Acute Leukemia and Lymphoma Relapse, a Cohort Study Analysis
Active, not recruiting NCT04904614 - Letermovir Use in Heart Transplant Recipients Phase 4
Completed NCT01986010 - Safety, Tolerability, and Immunogenicity of the Human Cytomegalovirus Vaccine (V160) in Healthy Adults (V160-001) Phase 1